None listed
Conditions
Brief summary
Pliant Inc. is developing PLN-74809-000 (hereafter referred to as PLN-74809) for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of primary sclerosing cholangitis (PSC). PLN-74809 is expected to exert anti-fibrotic effects through mechanisms that are different from those of current standards of care for the treatment of IPF. IPF remains a clear area of unmet medical need, warranting the development of novel therapies aimed at providing a clinically meaningful improvement for the IPF population. An oral solution of PLN-74809, which has been used in the clinical studies conducted thus far, is to be replaced by a newly developed tablet formulation. Accordingly, the current study is designed to determine the relative bioavailability of the tablet vs the solution as a reference in healthy participants.
Interventions
This will be a single center, 2-period, sequence-randomized, crossover, single-dose,
open-label study in 24 healthy participants. Participants will receive a single dose
of PLN 74809 on 2 occasions in randomized sequence, as an 40-mg oral solution and as a 40-mg tablet.
The 2 administrations will be separated by a washout period of approximately 2 weeks.
Intervention is administered directly by staff at a Phase 1 unit. Laboratory test will also be monitored to assess adherence.
Sponsors
Pliant Therapeutics, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18 to 55 years 2. Good general health, with no significant medical history and no clinically significant abnormalities at screening and/or before administration of the initial dose of study drug. 3. Body weight greater than or equal to 50 kg at the Screening Visit. 4. Body mass index (BMI) between 18 and 30 kg/m2, inclusive. 5. Participants must use adequate contraception for male and female participants of childbearing potential. 6. Understand the study procedures and agrees to participate in the study by giving written informed consent.
Exclusion criteria
- History of clinically significant abnormalities or diseases. - Pregnant or lactating females. - Positive test for hepatitis C antibody (HCVAb), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening. - Positive toxicology screening panel - History of substance abuse or dependency or history of recreational drug use. - Alcohol consumption greater than 14 drinks per week for males (7 for females). - Smokers or ‘vapers’ (cigarette or other modalities). - Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal supplements. - Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study. - Have participated in any other investigational drug trial within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.
Outcome results
None listed